The CONFIRM Registry

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
James K. Min, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01443637
First received: September 28, 2011
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

The CONFIRM study was developed to examine the prognostic value of cardiac computed tomographic angiography (CCTA) findings for prediction of future adverse cardiac events related to coronary artery disease (CAD) in a large, international patient population. The purpose of this multicenter registry is to correlate coronary and non-coronary cardiac findings by CCTA with demographic and clinical data for refinement of risk stratification of individuals with suspected or known CAD.


Condition
Atherosclerosis
Coronary Artery Disease
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: COronary CT Angiography Evaluation For Clinical Outcomes: An International Multicenter Registry

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Estimated Enrollment: 50000
Study Start Date: June 2003
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Coronary CT Angiography (CCTA)
Patients included in the CONFIRM Registry are those that have previously undergone clinically-indicated CCTA as part of their standard of care.

Detailed Description:

Coronary computed tomographic angiography (CCTA) of 64-detector rows or greater represents a novel noninvasive anatomic method for evaluation of patients with suspected coronary artery disease (CAD). Early studies suggest a potential for prognostic risk assessment by CCTA findings but were limited by small patient cohorts or single centers. The CONFIRM Registry is a large, prospective, multinational dynamic observational study of patients undergoing CCTA. The primary aim of CONFIRM is to determine the prognostic value of CCTA findings for the prediction of future adverse CAD events.

The CONFIRM registry currently represents 27,125 consecutive patients at 12 cluster sites in 6 countries in North America, Europe, and Asia. CONFIRM sites were chosen on the basis of adequate CCTA volume, site CCTA proficiency, and local demographic characteristics and medical facilities to ensure a broad-based sample of patients. Patients comprising the present CONFIRM cohort include those with suspected but without known CAD, with known CAD, or asymptomatic persons undergoing CAD evaluation. A data dictionary comprising a wide array of demographic, clinical, and CCTA findings was developed by the CONFIRM investigators and is uniformly used for all patients. Patients are followed up after CCTA performance to identify adverse CAD events, including death, myocardial infarction, unstable angina, target vessel revascularization, and CAD-related hospitalization.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study population consist of patients at multiple international centers undergoing clinically-indicated coronary CT angiography as part of their standard of care.

Criteria

All consecutive patients at cluster sites meeting all inclusion criteria undergoing CCTA of 64-detector rows or greater will be included within the CONFIRM registry.

Inclusion Criteria:

  1. Age > 18 years
  2. Evaluation by CCTA with 64-detector rows or greater for CAD evaluation as part of standard of care
  3. Interpretable CCTA
  4. Prospective data collection for CAD risk factors.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01443637

Locations
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Harbor UCLA
Los Angeles, California, United States
Cardiovascular Medical Group of Southern California
Los Angeles, California, United States
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States
United States, Florida
Baptist Cardiac and Vascular Institute
Miami, Florida, United States
United States, Georgia
Emory University
Atlanta, Georgia, United States
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
United States, New York
Capital Cardiology Associates
Albany, New York, United States
Weill Cornell Medical Center
New York, New York, United States
United States, Tennessee
Tenessee Heart and Vascular Institute
Hendersonville, Tennessee, United States
Austria
Medical University Innsbruck
Innsbruck, Austria
Canada, British Columbia
Providence Health Care
Vancouver, British Columbia, Canada
Canada, Ontario
Ottawa Heart Institute
Ottawa, Ontario, Canada
Germany
University of Giessen
Giessen, Germany
Deutsches Herzzentrum Munchen
Munich, Germany
Italy
University of Parma
Parma, Italy
Korea, Republic of
Severance Cardiovascular Hospital
Seoul, Korea, Republic of
Seoul National University College of Medicine
Seoul, Korea, Republic of
Switzerland
University Hospital of Zurich
Zurich, Switzerland
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: James K Min, MD Cedars-Sinai Medical Center
  More Information

Publications:
Responsible Party: James K. Min, Associate Professor of Medicine, David Geffen UCLA School of Medicine; Associate Professor of Medicine, Imaging and Biomedical Sciences; Director of Cardiac Imaging Research; Co-Director of Cardiac Imaging, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01443637     History of Changes
Other Study ID Numbers: CTG1
Study First Received: September 28, 2011
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Coronary Artery Disease
CAD
Atherosclerosis
Myocardial Infarction
MI
CONFIRM
Coronary Computed Tomographic Angiography
CCTA

Additional relevant MeSH terms:
Atherosclerosis
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on April 17, 2014